Overview:
Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management.
To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

Related listings

The Next Level of Private Practice journeys into practice development expert Howard Baumgarten's trademark "four R's." These R's include Risk, Referrals, Retention, and Resilience. Each of these four areas possesses specific meaning to the practice o...

Overview: This is an interactive overview of how DMAIC can be utilized in a home environment to improve the quality of life for a child diagnosed as being on the Autism Spectrum. Why should you Attend: The same tools and skills can be applied to any ...